MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	INGENIA ELITION X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The qbc that was damage was replaced and the system was handed back to the customer for use.The failure of the qbc to remain in place is considered a malfunction.Remedial action: a field action was initiated under 2023-pd-mr-013.A field safety notification was sent to the customers informing them about this potential issue.The field correction has since been made available to the field in dec 2024.
Event or Problem Description
Philips received a report that the quadrature body coil was damage.This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the magnet covers.If this seal is damage it is likely that this could lead to serious injury.
Additional Manufacturer Narrative
This is a correction report as the report previously sent is for a 70 cm system, ingenia elition x, which is not affiliated with the c&r on the 60cm systems listed in c&r 2023-pd-mr-013.Based on the information received in the complaint record we confirm that it is not a reportable product problem.During the risk evaluation for the 70cm systems, the reasonably foreseeable sequence of events was assessed, and residual risk was estimated as potential risk based on a detailed review of post-market data.This conservative assessment concludes that the estimated potential risk of continued scanning with a missing or damaged qbc seal on 70cm wide bore mr systems is improbable to cause any adverse health consequences.The immediate and long-term health consequences to the overall population using the device due to the hazard: energy-mechanical / sharp edges, corners, rough surfaces, are considered: improbable to cause serious adverse health consequences (i.E., potential s3 harms), and improbable to cause medically reversible or transient adverse health consequences (i.E., potential s1 and s2 harms).In addition, as per anthropometric data [ref-1], the whole body breadth of the 95th percentile of the u.S.Population, with a highest obesity rate globally [ref-2], measured 65.6 cm.This suggests that most people can be accommodated by 70 cm bore systems with a 68.9 cm internal width.As such, getting this type of harm on a 70cm system is considered rarer when compared to a smaller sized bore (i.E., 60cm).According to the above risk assessment, the issue under evaluation has not been determined to be a risk to health.Reference 1: bradtmiller, b., hodge, b., kristensen, s., & mucher, m.(2008).Anthropometric survey of federal aviation administration technical operations personnel - 2006-2008.Yellow springs, oh: anthrotech reference 2: world obesity federation, world obesity atlas 2023.Https://data.Worldobesity.Org/publications/?cat=19.
Event or Problem Description
Philips received a report that the quadrature body coil seal was damage.This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the magnet covers.

• Brand Name: INGENIA
• Common Device Name: FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 22409452
• Report Number: 3003768277-2025-006093
• Device Sequence Number: 15947057
• Product Code: LNH
• UDI-Device Identifier: 00884838088115
• UDI-Public: (01)00884838088115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INGENIA ELITION X
• Device Catalogue Number: 781358
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2023-PD-MR-013
• Patient Sequence Number: 1
• Patient Sex: Unknown